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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04056702
Other study ID # HS-3236
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 5, 2019
Est. completion date July 2022

Study information

Verified date March 2021
Source National Jewish Health
Contact Connor Balkissoon
Phone 877-225-5654
Email balkissoonc@njhealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.


Description:

To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus CT scan and complete questionnaires related to signs and symptoms of sinus disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 31
Est. completion date July 2022
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: 1. Subjects from 18 to 89 years old. 2. Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record). 3. Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride > 90 mmol/L. Exclusion Criteria: 1. Subjects under the age of 18 or over the age of 89. 2. Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons. 3. Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period. 4. Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Elexacaftor-tezacaftor-ivacaftor exposure
Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study.

Locations

Country Name City State
United States National Jewish Health Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
Jennifer Taylor-Cousar Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Sinus CT opacification. Calculated from an automated quantification of the size of sinuses. Change in Sinus CT opacification between the initial and 6 month visits.
Secondary Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score. Validated, disease-specific measure of sinus symptoms. Contains 22 questions that are all scored from 0 to 5, when summed a total score ranges form 0 to 110. Higher scores represent worse sinus symptoms. Change in SNOT-22 score between the initial and 6 month visits.
Secondary Change in Questionnaire for Olfactory Disorders (QOD) score Validated, disease-specific measure of olfaction, i.e. the ability to smell. Contains 19 questions that are scored form 0 to 3, when summed a total score can range form 0 to 57. Higher scores indicate greater impact on a subjects sense of smell. Change in QOD score between the initial and 6 month visits.
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